Volar distal radius stabilization system

ABSTRACT

Devices, systems, and methods for bone stabilization, especially volar distal radius stabilization. The stabilization system may include a bone plate having an elongated portion, an enlarged head portion, and a transition region connecting the elongated portion to the enlarged head portion, and the plate including a plurality of through holes. A plurality of fasteners may be configured to extend through one or more of the plurality of through holes in the bone plate and into the bone. The plate may be used to stabilize a fracture in a long bone, such as a radius.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation-in-Part of U.S. patentapplication Ser. No. 15/238,773, filed on Aug. 17, 2016, the contents ofwhich are incorporated herein in their entirety by reference for allpurposes.

FIELD

The present disclosure relates to surgical devices and stabilizationsystems, for example, for trauma applications, and more particularly,for stabilization of volar distal radius fractures.

BACKGROUND

Bone fractures are often repaired by internal fixation of the bone, suchas diaphyseal bone, using one or more plates. The plate is held againstthe fractured bone with screws, for example, which engage the bone andheads which provide a compressive force against the plate. The plate andbone are thus forced against each other in a manner that transfers loadprimarily between a bone contacting surface of the plate and the bonesurface to reinforce the fractured bone during healing. This manner ofplating generally creates relatively low stress concentration in thebone, as there may be a large contact area between the plate and thediaphyseal bone surface permitting transfer of load to be dispersed.There may be a desire to use locking screws, non-locking screws, or acombination of both that are able to dynamically compress the bone. Ofcourse, the designs of the plates, types of screws, and locking and/ornon-locking capabilities may vary based on the location and type offracture.

The three long bones of the upper extremity are the humerus, radius, andulna. In the case of radial fracture fixation, a volar approach may besuitable for plating certain fracture types. There remains a need,however, for improved plating systems for anatomical articular reductionand stable fixation of the radius.

SUMMARY

To meet this and other needs, devices, systems, and methods of bonestabilization are provided, for example, for radius stabilization. Thevolar distal radius stabilization systems may include one or more platesand one or more fasteners. Although generally described with referenceto the radius, it will be appreciated that the stabilization systemsdescribed herein may be used or adapted to be used for the fixation ofother long bones as well, such as the humerus, femur, tibia, etc.

According to one embodiment, a stabilization system includes a boneplate and a plurality of fasteners. The bone plate comprises anelongated portion extending along a longitudinal axis, an enlarged headportion, and a transition region connecting the elongated portion to theenlarged head portion, wherein the transition region is curved andconnect to an end portion of the enlarged head portion, the bone platecomprising a plurality of through holes extending through the enlargedhead portion, the transition region, and the elongated portion. Thefasteners are configured to extend through one or more of the pluralityof through holes in the bone plate and configured to secure the boneplate to the bone.

The fasteners may include locking fasteners (e.g., configured to lock tothe plate), non-locking fasteners (e.g., configured to provide dynamiccompression of the bone), polyaxial fasteners (e.g., configured to beinserted at a plurality of angles or trajectories), fixed anglefasteners (e.g., configured to be inserted at a fixed angle ortrajectory), or any other suitable fasteners known in the art.

In some instances, the locking fasteners may include fasteners havingself-forming threads on a head portion of the fasteners, which areconfigured to lock to at least one of the plurality of through holes onthe plate.

According to another embodiment, a stabilization system configured tostabilize a radius includes a bone plate, a plurality of fixed anglefasteners, a polyaxial fastener, and a fastener. The bone platecomprises an elongated portion extending along a longitudinal axis, anenlarged head portion, and a transition region connecting the elongatedportion to the enlarged head portion, wherein the transition region iscurved and connect to an end portion of the enlarged head portion, thebone plate comprising a plurality of fixed angle holes positioned ingeneral alignment along the elongated portion, a polyaxial holepositioned proximate to the end portion of the enlarged head portionconnected to the transition region, and an elongated slot on theelongated portion. The fixed angle fasteners are configured to bereceived in the fixed angle holes, the plurality of fixed anglefasteners configured to be aimed at a radio-carpal joint and a distalradio-ulnar joint. The polyaxial fastener is configured to be receivedin the polyaxial hole, the polyaxial fastener configured to be aimed ata radial styloid. The fastener is configured to be received in theelongated slot, wherein the elongated slot allows for proximal-distaland medial-lateral adjustment of the plate.

According to another embodiment, a stabilization system for stabilizinga bone includes a bone plate and a plurality of fasteners. The boneplate has an upper surface and a lower surface configured to contact thebone, wherein the lower surface comprises one or more recessesconfigured to reduce contact between the plate and a surface of thebone. The bone plate comprises an elongated portion extending along alongitudinal axis, an enlarged head portion, and a transition regionconnecting the elongated portion to the enlarged head portion, whereinthe transition region is connect to an end portion of the enlarged headportion and the other end portion of the enlarged head portion is a freeend, the bone plate comprising a plurality of through holes extendingthrough the enlarged head portion, the transition region, and theelongated portion. The plurality of fasteners are configured to extendthrough one or more of the plurality of through holes in the bone plateand configured to secure the bone plate to the bone.

According to yet another embodiment, one or more methods of installing astabilization system may include aligning a bone plate against the volarside of the radial bone, and inserting one or more fasteners through thebone plate and into the bone to stabilize the radius and repair thefracture.

Also provided are kits for the stabilization systems including boneplates of varying sizes and orientations, fasteners including lockingfasteners, non-locking, compression fasteners, polyaxial fasteners,fixed angle fasteners, or any other suitable fasteners, drill guides,k-wires, and other components for installing the same.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIGS. 1A-1J depict stabilization systems according to embodimentsincluding volar distal radius bone plates and a plurality of bonefasteners;

FIG. 2 is a top perspective view of two fasteners engaged withcombination holes according to an embodiment;

FIG. 3 is a close-up view of an alternative version of a combinationhole according to another embodiment;

FIGS. 4A-4C show a perspective view, top view, and cross-section view,respectively, of an another embodiment of a combination hole;

FIGS. 5A-5C show a perspective view, top view, and cross-section view,respectively, of an another embodiment of a combination hole;

FIGS. 6A-6C show a perspective view, top view, and cross-section view,respectively, of an another embodiment of a hole for receiving afastener;

FIGS. 7A-7C show a perspective view, top view, and cross-section view,respectively, of an another embodiment of a combination hole;

FIGS. 8A-8C show a perspective view, top view, and cross-section view,respectively, of an another embodiment of separate locking andnon-locking holes;

FIGS. 9A-9D show a perspective view, a top view, a cross-section view,and a perspective view with a locking fastener, respectively, accordingto another embodiment of a plate including three overlapping locking andnon-locking holes;

FIGS. 10A-10B show perspective views of a plate according to anotherembodiment with locking and non-locking functionality;

FIGS. 11A-11E shows alternative locking screw and openings in platesaccording to yet another embodiment;

FIGS. 12A and 12B depict a perspective view and cross-section view of analternative version of a plate with blocking screws;

FIGS. 13A and 13B depict a fastener according to another embodiment withself-forming threads configured to form threads in the opening of aplate;

FIGS. 14A and 14B depict an opening in a plate according to oneembodiment having a windswept cut configured to receive the self-formingthreads of the fastener of FIGS. 13A-13B;

FIGS. 15A and 15B depict an opening in a plate according to anotherembodiment having a knurled cut configured to receive the self-formingthreads of the fastener of FIGS. 13A-13B;

FIGS. 16A and 16B depict an opening in a plate according to anotherembodiment having a polygonal cut configured to receive the self-formingthreads of the fastener of FIGS. 13A-13B;

FIG. 17A depicts an alternative opening in a plate according to anotherembodiment;

FIG. 17B depicts another alternative opening in a plate according to yetanother embodiment;

FIGS. 18A-18D depict a plate assembly according to one embodiment wherea locking or non-locking fastener may be positioned at an angle orperpendicular to the plate;

FIG. 19 depicts a stabilization system according to one embodimentincluding a volar distal radius dia-meta bone plate;

FIG. 20 depicts a stabilization system according to one embodimentincluding an acute dorsal bone plate.

FIG. 21 is a cross sectional view of the dorsal bone plate of FIG. 20;

FIG. 22 depicts a stabilization system according to one embodimentincluding an oblique dorsal bone plate;

FIG. 23 depicts dorsal bone plates of FIGS. 20 and 22 with fixationscrews;

FIG. 24 is a close up view of a portion of the dorsal bone plates ofFIGS. 20 and 22;

FIG. 25 depicts a stabilization system according to one embodimentincluding a lateral bone plate.

FIG. 26 is a cross sectional view of the lateral bone plate of FIG. 25;

FIG. 27 depicts the lateral bone plate of FIG. 25 with fixation screws;

FIG. 28 depicts a stabilization system according to one embodimentincluding a bridge bone plate;

FIG. 29 depicts a stabilization system according to one embodimentincluding a lunate facet hook plate;

FIG. 30 depicts the lunate facet hook plate of FIG. 29 with a fixationscrew;

FIG. 31 depicts the volar distal radius plate of FIG. 1 used with thelunate facet hook plate of FIG. 30;

FIGS. 32 and 33 depict a lunate facet hook plate reduction instrument;and

FIGS. 34 and 35 depict a backpack drill guide for use with at least thevolar distal radius plates of FIG. 1.

DETAILED DESCRIPTION

Embodiments of the disclosure are generally directed to devices,systems, and methods for bone stabilization, especially radiusstabilization. Specifically, embodiments are directed to volar distalradius stabilization systems including a bone plate configured to sitagainst the volar side of the radial bone. The fasteners may beconfigured to secure the bone plate to the radius. Still otherembodiments are directed to different types of holes and fastenersconfigured to provide locking and/or compression to the bone.

The bone plate may be comprised of titanium, stainless steel, cobaltchrome, carbon composite, plastic or polymer—such aspolyetheretherketone (PEEK), polyethylene, ultra high molecular weightpolyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolicacid (PGA), combinations or alloys of such materials or any otherappropriate material that has sufficient strength to be secured to andhold bone, while also having sufficient biocompatibility to be implantedinto a body. Similarly, the fasteners may be comprised of titanium,cobalt chrome, cobalt-chrome-molybdenum, stainless steel, tungstencarbide, combinations or alloys of such materials or other appropriatebiocompatible materials. Although the above list of materials includesmany typical materials out of which bone plates and bone fasteners aremade, it should be understood that the bone plates and fastenerscomprised of any appropriate material are contemplated.

The embodiments of the disclosure and the various features andadvantageous details thereof are explained more fully with reference tothe non-limiting embodiments and examples that are described and/orillustrated in the accompanying drawings and detailed in the followingdescription. The features of one embodiment may be employed with otherembodiments as the skilled artisan would recognize, even if notexplicitly stated herein. Descriptions of well-known components andprocessing techniques may be omitted so as to not unnecessarily obscurethe embodiments of the disclosure. The examples used herein are intendedmerely to facilitate an understanding of ways in which the disclosuremay be practiced and to further enable those of skill in the art topractice the embodiments of the disclosure. Accordingly, the examplesand embodiments herein should not be construed as limiting the scope ofthe disclosure, which is defined solely by the appended claims andapplicable law. Moreover, it is noted that like reference numeralsrepresent similar features and structures throughout the several viewsof the drawings.

Volar Distal Radius Plate System

Referring now to the drawing, FIGS. 1A-1J depict embodiments of a volardistal radius stabilization system 100 including a bone plate 110configured to sit against the volar side of the radial bone and one ormore bone fasteners 130 configured to be received in the bone plate 110and secured to the radius 102. The radius 102 or radial bone is one ofthe two large bones of the forearm, the other being the ulna. The radius102 extends from the lateral side of the elbow to the thumb side of thewrist and runs parallel to the ulna, which exceeds it in length andsize. Near the wrist, the distal end 104 of the radius 102 is large andof quadrilateral form. Although generally described with reference tothe radius 102, it will be appreciated that the stabilization systemsdescribed herein may be used or adapted to be used for the fixation ofother long bones as well, such as the humerus, femur, tibia, etc.

The bone plate 110 extends from a first end 112 configured to bepositioned proximate to a shaft portion of radius 102 to a second end114 configured to be positioned proximate to the distal end 104 of theradius 102. The plate 110 includes a top surface 116 and an opposite,bottom surface 118 configured to contact adjacent bone. The top andbottom surfaces 116, 118 are connected by opposite side surfacesextending from the first to second ends 112, 114 of the plate 110. Thebottom surface 118 of the plate 110 includes an anatomic contourconfigured to follow the best approximation of average distal radialanatomy, flaring up slightly along the radial column and moresignificantly along the intermediate column of the plate 110. The plate110 is designed to sit low and have a generally low profile proximalportion. The thickness of the plate 110 may generally be about 2 mmalong the shaft and distal intermediate column, tapering to a thicknessof 2.5 mm along the distal radial column which allows for the severeangle of the radial styloid fastener. The watershed line of the volardistal radius defines the border between the radiocarpal (RC) joint andthe volar surface of the radius 102. A chamfer at the second end 114 onthe distal radius column of the plate 110 may help to ensure minimaltendon disruption, for example of the flexor pollicus longus and flexorcarpi radialis, by maintaining a lower profile over the tendon sites.

The bone plate 110 includes an elongated portion 140 extending along alongitudinal axis L, having a length greater than its width. Theelongated portion 140 is configured to contact the shaft of the radius102. The elongated portion 140 may terminate at the first end 112 with ataper such that it has a width and/or thickness less than the remainderof the elongated portion 140. A transition region 144 may connect theelongated portion 140 to an enlarged head portion 142. The transitionregion 144 may extend along an axis T which is generally angled relativeto the axis L of the elongated portion 140. The transition region 144may extend at an angle X relative to the elongated portion 140. Theangle X of the transition region 144 relative to the elongated portion140 may range from about 10-60°, about 20-50°, about 30-40°, about40-50°, or another appropriate angle. The transition region 144 maygenerally form a curve from the elongated portion 140 to an end of theenlarged head portion 142.

The transition region 144 may connect to an end portion of the enlargedhead portion 142 and the other end portion of the enlarged head portion142 may be a free end. In other words, the opposite end portion of theenlarged head portion 142, not connected to the transition region 144,is not connected to any other portion of the plate 110. The free end ofthe enlarged head portion 142 may be separated a distance from thetransition region 144 and the elongated portion 140 of the plate 110.

The enlarged head portion 142 or a portion thereof is configured tocontact the distal end 104 of the radius 102. The enlarged head portion142 has a width greater than the width of the elongated portion 140. Theenlarged head portion 142 extends along an axis A at an angle Y relativeto the transition region 144. The angle Y of the head portion 142relative to the transition region 144 may range from about 10-60°, about20-50°, about 30-40°, about 40-50°, or another appropriate angle.Accordingly, the axis A of the enlarged head portion 142 may betransverse to the axis L of the elongated portion 140. In someembodiments, the axis A of the enlarged head portion 142 may begenerally perpendicular to the axis L of the elongated portion 140. Asbest seen in FIG. 1C, the bone plates 110 may be available in a varietyof lengths and sizes based on the anatomy of the patient. The plates 110are configured to sit against the volar side of the radial bone 102. Theplates 110 are configured in both left and right designs, in a mirroredconfiguration, in order to address the anatomy of both the left andright arms of the patient.

As best seen in FIGS. 1H and 1I, the bottom surface 118 of the plate 110may include a plurality of recesses 119 located along the elongatedportion 140 between the fastener openings 120. In the embodiment shownin FIG. 1H, the recesses 119 are in the form small partial bores in thelateral surface, which are configured to facilitate bending of the plate110. The recesses 119 remove material such that the plate 110 shieldstress from the fastener openings 120, discouraging hole warping effectduring recontouring of the plate 110. The recesses 119 may also provideattachment points for plate placement instrumentation (not shown). Inthe embodiment shown in FIG. 1I, the recesses 119 are in the form ofscallop cuts having partially cylindrical valleys cut around a peripheryof the bottom surface 118 of the plate 110. This again shields stressfrom the fastener openings 120 during bending, discouraging hole warpingeffects while recontouring the plate 110. This also reduces contactbetween the plate 110 and the bone surface, thereby helping to preserveblood supply to the bone and prevent osteonecrosis. In addition to or inplace of the recesses 119, a plurality of dimples, best seen in FIG. 1J,may be positioned along the bottom surface 118 of the plate 110 (e.g.,along the entire bottom surface 118 or a portion thereof) to furtherreduce contact between the plate 110 and bone surface, further helpingto preserve blood supply and prevent osteonecrosis.

The plate 110 includes one or more through openings 120 configured toreceive one or more bone fasteners 130. The openings 120 extend throughthe body of the plate 110 from the top surface 116 to the bottom surface118. The openings 120 may include cylindrical openings, conicalopenings, elongated openings, threaded openings, textured openings,non-threaded and/or non-textured openings, and the like. The openings120 may allow for locking of the fastener 130 to the plate 110 or mayallow for movement and dynamic compression of the bone. The plate 110may comprise any suitable number of openings 120 in any suitableconfiguration. These openings 120 allow surgeons more flexibility forfastener placement, based on preference, anatomy, and fracture location.Surgeons may have differing opinions as to the number, location, andtypes of fasteners 130. Further, complexity of fracture location andshape makes having as many locations for fasteners 130 as possiblenecessary. This design offers surgeons a versatile method to achievehigher accuracy in placement of the fasteners 130.

The openings 120 may be configured to receive one or more bone fasteners130. The fasteners 130 may include locking fasteners, non-lockingfasteners, or any other fasteners known in the art. The fasteners 130may comprise bone screws or the like. The fasteners 130 may also includeother fasteners or anchors configured to be secured or engaged withbone, such as nails, spikes, staples, pegs, barbs, hooks, or the like.The fasteners 130 may include fixed and/or variable angle bone screws.The fastener 130 may include a head portion 132 and a shaft portion 134configured to engage bone. For a locking fastener 130, the shaft portion134 may be threaded such that the fastener 130 may be threaded into thebone. The head portion 132 may include a textured area, such as threads,around its outer surface sized and configured to engage with the opening120, for example, and corresponding threads in the opening 120 in orderto lock the fastener 130 to the plate 110. In the alternative, for anon-locking fastener 130, the head portion 132 may be substantiallysmooth to allow for dynamic compression of the bone.

In one embodiment, the enlarged head portion 142 of the plate 110includes a plurality of holes 120A are aligned so that their nominaltrajectories follow the articular surfaces of both the radio-carpaljoint and the distal radio ulnar-joint. This allows the fasteners 130Ato buttress and support the articular surfaces during fracturereconstruction. As shown in the embodiment in FIGS. 1A-1C, the plate 110may have a single row of holes 120A generally in alignment and asecondary hole 120A positioned on the transition region 144. FIG. 1Cdepicts one embodiment of the plate 110 (right most plate 110) having afirst, distal row of holes 120A generally in alignment and a second rowof holes 120A generally in alignment. The second row of holes 120A mayreceive fasteners 130A with trajectories converging with the distal rowscrew trajectories. In an alternative version of the stabilizationsystem 100, shown in FIGS. 1D and 1E, the elongated portion 140 directlytransitions into the enlarged head portion 142 and the enlarged headportion 142 is increased in dimension in order to receive the second rowof the fasteners 130A.

The holes 120A may be fixed openings configured to accept fixed anglefasteners 130A that can be secured into the distal end 104 of the radius102. The screw holes 120A and screw heads 132 may have mating conicalthreads that lock the screw 130A in both angular and axial alignment toprevent collapse and backout. The fasteners 130A may have predeterminedtrajectories based on the orientations of the openings 120A. An upperportion of the holes 120A may be tapered 128 to allow for the properpositioning of each of the fasteners 130A. Each of the fasteners 130Amay be angled along a different trajectory than the other respectivefasteners 130A. Some of the fasteners 130A may have a greater angulationthan other respective fasteners 130A.

The enlarged head portion of the plate 110 further include a hole 120Bconfigured to receive fastener 130B with a trajectory having the severeangle necessary to reach the tip of the radial styloid. An upper portionof the hole 120B may be tapered 128 and a portion of the plate 110around the hole 120B may be enlarged or increased in thickness to allowfor the proper angle of the fasteners 130B to be achieved. The fastener130B may be in the form of a polyaxial bone screw, which may begenerally larger (e.g., in length and/or diameter) than the otherfasteners 130 securing the plate 110 to the bone. The fasteners 130A,130B are optionally cannulated to allow for precise placement with ak-wire (not shown) if desired by the surgeon. In some embodiments, thefasteners 130A, 130B may include polyaxial screws having self-formingthreads that work by displacement of the plate material, which aredescribed in more detail herein.

The plate 110 also include one or more holes 120C present along theelongated portion 140 of the plate 110 and configured to accommodate acompression fastener 130C. As best seen in FIG. 1G, the holes 120C mayoffer a sliding slot for proximal-distal adjustment of the plate 110during provisional placement. The slot 120C may allow for proximaladjustment, distal adjustment, and/or medial-lateral adjustment of theplate 110. This allows surgeons to optimally center the plate positionalong the bone prior to locking screw insertion. The hole or holes 120Cmay be elongated along the longitudinal axis L of the elongated portion140 as well as elongated, relative to the fastener 130C, from lateralside to lateral side. The elongated hole or holes 120C may have varyinglengths and/or widths. Preferably, the length is greater than the widthof the slot 120C.

The hole 120C may be configured to accommodate non-locking, compressionscrews 130C, the heads of which have a spherical underside, so the screw130C may be placed at varying angles. The compression screw 130C can beinserted and preliminarily tightened to secure the plate 110 to thebone. As the screw 130C is inserted eccentrically in to the hole 120C,the screw 130C slides down the slot 120C, displacing the plate 110 andthe bone as well. The compression screw 130C may have a shorter lengthand/or a smaller diameter than the screws 130A and/or 130B. If the plate110 needs to be adjusted later, the screw 130C can be loosened and theplate 110 can be shifted in the proximal, distal, and/or medial-lateraldirections. This slot 120C also accommodates reduction of the radius 102by inserting a longer compression screw 130C and pulling the bone to theplate 110.

The plate 110 may include one or more holes 120D present along theelongated portion 140 of the plate 110 configured to secure the plate110 to the shaft of the radius 102. The holes 120D may be configured toaccommodate fixed and/or variable angle fasteners 130D. For lockingfasteners 130D, the screw holes 120D and screw heads 132 may have matingconical threads that lock the screw 130D in both angular and axialalignment to prevent collapse and backout. An upper portion of the holes120D may be tapered 128, for example, around the perimeter of the hole120D, to allow for the proper positioning of each of the fasteners 130D.For non-locking fasteners 130D, the head portion 132 may besubstantially smooth to allow for dynamic compression of the bone.

The plate 110 including head portion 142 and/or the elongated portion140 may further comprise a plurality of openings 124 configured toreceive one or more k-wires (not shown). The k-wire holes 124 maycomprise small diameter holes (e.g., having a diameter significantlysmaller than the fastener openings 120). The k-wire holes 124 may allowpreliminary placement of the plate 110 against the bone and/or to aid inreduction of the fracture. The distal k-wire holes 124 on the headportion 142 may ensure a trajectory to follow the RC joint and providedirection during insertion of the distal locking screws. The proximalk-wire holes in the elongated portion 140 of the plate 110 are arrangebetween fastener openings 120 and may be angled relative to the surfaceof the plate 110 to avoid intrusion into areas where instrumentationmust pass during screw insertion.

In the embodiment shown in FIGS. 1D and 1E, the plate 110 may alsocomprise a window 126. The window 126 may provide visualization of theplate 110 with respect to the radius 102 in the operating environmentand on imaging (e.g., fluoroscopy). The window 126 is show as generallyan asymmetrical triangle, but it envisioned that the window 126, ifpresent, may be of any suitable shape, size, and dimension.

The bone plate 110 may be attached to a proximal humerus to fixate oneor more bone fractures or fragments and thereby promote healing of thebone. In one embodiment, the plate 110 further restores the anatomicalignment of the radius 102. The plate 110 may be positioned against thevolar side of the radial bone. One or more k-wires may be suppliedthrough the k-wire holes 124 to assist with preliminary placement of theplate 110. Pilot holes may be drilled through the fastener openings 120to prepare to receive the respective fasteners 130. The fasteners 130A,130B, 130C, 130D may be positioned through the respective openings 120A,120B, 120C, 120D and into the radius 102. The fasteners 130 may beaffixed to the bone in any suitable order, number, and orientationdepending on the anatomy of the bone and the fracture.

Alternative Hole Configurations

The fixed and variable angle, locking and non-locking openings 120, 220(e.g., including openings 120A, 120B, 120C, 120D) and respectivefasteners 130, 230 (e.g., including 130A, 130B, 130C, 130D) describedherein may be substituted with or include one or more of the followingopenings 20 and/or fasteners 30, 40. The openings 20 and/or fasteners30, 40 are generally described with reference to a generic plate 10,which may include plate 110, 210, 310, 410, 510, 610, or any othersuitable plate design.

Referring now to the drawing, FIGS. 2-18 depict alternative openings 20in plate 10. The openings 20 extending through the plate 10 areconfigured to accept locking fasteners 30, non-locking fasteners 40, ora combination of both locking and non-locking fasteners 30, 40 that areable to dynamically compress the bone and/or affix the plate 10 to thebone. When plating diaphyseal bone, surgeons may use a combination ofboth locking and non-locking fasteners 30, 40 that are able todynamically compress bone and to connect the bone and the plate 10.Dynamic compression may also be desirable to create interfragmentalcompression while tightening the fasteners 30, 40.

The plate 10 includes a top surface 16 and an opposite, bottom surface18 configured to contact adjacent bone. The plate 10 includes one ormore through openings 20 configured to receive one or more bonefasteners 30, 40. The openings 20 extend through the body of the plate10 from the top surface 16 to the bottom surface 18. In the embodimentsdepicted in FIGS. 2-3, for example, the openings 20 may be in the formof a combination opening that has at least two overlapping holes. Asshown in FIG. 2, the combination opening 20 includes a first hole 22overlapping a second hole 24. One of the holes 22 may be configured tobe the locking hole 22, thereby able to receive and secure the lockingfastener 30 to the plate 10, and the other of the holes 24 may beconfigured to be the dynamic compression hole 24, thereby allowing thenon-locking fastener 40 to freely move in the hole 24 and apply dynamiccompression. The locking hole 22 may have one or more locking featuresdesigned to engage with a locking fastener 30, and the dynamiccompression hole 24 may be elongated, for example, along the centrallongitudinal axis of the plate 10. The screw holes 22, 24 are notconstrained to parallel axes. This hole geometry may be used in boneplates 10 to utilize either fixed angle or variable angle locking screws30 and/or polyaxial non-locking screws 40 that can achieve dynamiccompression.

These openings 20 allow surgeons more flexibility for fastenerplacement, based on preference, anatomy, and fracture location. Surgeonsmay have differing opinions as to whether non-locking or locking screws30, 40 (or some combination of the two) should be used in diaphysealbone. Further, complexity of fracture location and shape makes having asmany locations for fasteners 30, 40 as possible necessary. This designoffers surgeons a versatile method to achieve higher accuracy inplacement of locking and/or non-locking screws 30, 40.

As best seen in FIG. 2, the locking and non-locking fasteners 30, 40 areshown. The locking and non-locking fasteners 30, 40 may includetraditional fasteners known in the art. The locking and non-lockingfasteners 30, 40 may comprise bone screws or the like. The fasteners 30,40 may also include other fasteners or anchors configured to be securedor engaged with bone, such as nails, spikes, staples, pegs, barbs,hooks, or the like. The fasteners 30, 40 may include fixed and/orvariable angle bone screws.

The locking fastener 30 may include a head portion 32 and a shaftportion 34 configured to engage bone. The shaft portion 34 may bethreaded such that the fastener 30 may be threaded into the bone. Thehead portion 32 of the locking fastener 30 includes a textured area 36around its outer surface sized and configured to engage with the lockinghole 22 of the combination opening 20. The textured area 36 may includethreads, ridges, bumps, dimples, serrations, or other types of texturedareas. As shown, the texture area 36 preferably includes a threadedportion extending substantially from the top of the head portion 32 tothe bottom of the head portion 32 proximate to the shaft portion 34.Thus, when the textured area 36 engages the locking hole 22, the lockingfastener 30 is thereby locked to the plate 10.

The non-locking fastener 40 includes a head portion 42 and a shaftportion 44 configured to engage bone. The shaft portion 44 may bethreaded such that the fastener 40 may be threaded into the bone. Thehead portion 42 of the non-locking fastener 40 is substantially smootharound its outer surface such that is able to slide along the elongatedcompression hole 24. Thus, the non-locking fastener 30 may be coupled tothe plate 10, but not locked thereto to enable dynamic compression ofthe bone. It will be recognized that the head portions 32, 42 of thefasteners 30, 40 may include a recess configured to receive a driver orthe like.

The locking hole portion 22 of the combination opening 20 includes atextured portion 26. The textured portion 26 may include threads,ridges, bumps, dimples, serrations, knurls, or other types of texturedareas. The textured portion 26 may be of the same type (e.g., matingsurfaces) or different from the textured area 36 of the locking fastener30. As shown, the textured portion 26 is serrated or knurled along aninner portion of the hole 22. The knurled surface may include straight,angled, or crossed lines cut or rolled into the material. In theembodiment shown in FIG. 2, the textured portion 26 extends alongsubstantially the entire inner surface of the hole 22. With reference tothe embodiment shown in FIG. 3, the combination hole 20 is substantiallythe same as that shown in FIG. 2 except that the textured portion 26 thelocking hole 22 now includes a thin centralized textured ribbon ofmaterial. For example, the textured portion 26 takes up about half orless of the surface area of the hole 22. In this instance, only aportion of the textured area 36 of the head portion 32 of the lockingfastener 30 engages with and locks to the textured portion 26 of thehole 22.

An upper portion of the hole 22 may be tapered 28, without texturing,for example, to facilitate alignment of the fastener 30 with the opening20. As shown in FIG. 3, this tapered portion 28 is enlarged in arearelative to the embodiment in FIG. 2. The hole 22 may be configured toreceive a fixed or variable angle fastener 30. The hole 22 may begenerally conical in shape such that it is wider near the top surface 16of the plate 10 and narrower toward the bottom surface 18 of the plate10. The tapered portion 28 and/or the textured area 26 may be conical inshape. In this embodiment, the locking hole 22 is a textured fixed angleconical hole configured to receive locking fastener 30. The texturedholes 22 may deform as the fastener head 32 interferes with the texturedportion 26 of the hole 22, thereby providing a positive lock between thefastener 30 and the plate 10.

The second hole portion 24 of the combination opening 20 may be anelongated dynamic compression hole. The dynamic compression hole 24 maybe elongated such that it has a length greater than its width. The hole24 may be elongated along the longitudinal axis of the plate 10. In thealternative, the hole 24 may be generally cylindrical such that the hole24 only permits polyaxial movement of the fastener 40. The inner surfaceof the hole 24 may be substantially smooth such that the non-lockingfastener 40 is able to freely pivot and/or slide along the hole 24. Thisprovides for at least two directions of compressive force (e.g., alongthe longitudinal axis and perpendicular to the longitudinal axis of theplate 10). The head portion 42 of the non-locking fastener 40 may besubstantially smooth around its outer surface. The head portion 42 issized and configured to engage with and be retained within the holeportion 24 of the combination opening 20. The hole 24 may be configuredto receive a fixed or variable angle fastener 40. In one embodiment, thehole 24 may be generally conical in shape and/or tapered such that it iswider near the top surface 16 of the plate 10 and narrower toward thebottom surface 18 of the plate 10. In this embodiment, the hole 24 is asmooth variable angle conical hole configured to receive the non-lockingfastener 40. The hole 24 may receive the fastener head 42 allowingmovement of the fastener 40, for example, in a polyaxial fashion and/oralong the length of the hole 22, thereby providing dynamic compressionof the bone.

Turning now to FIGS. 4-7, alternative types of openings 20A-20G, whichprovide for locking and/or non-locking, dynamic compression areprovided. As many of the features of these openings are similar to thecombination openings 20 described already for FIGS. 2-3, only thedifferent features will be further explained.

With reference to FIGS. 4A-4C, the combination opening 20A is similar tocombination opening 20 except that the dynamic compression hole 24A hasthe same general diameter as the locking hole 22A, and the locking hole22A includes a different type of textured portion 26A. In thisembodiment, the locking hole 22A has a first diameter D1, and thedynamic compression hole 24A has a second diameter D2. Unlike theelongated hole 24 described earlier, dynamic compression hole 24A hassubstantially same diameter as the locking hole 22A. Thus, the first andsecond diameters D1, D2 are substantially the same. The hole 24A may beformed by milling or drilling a sphere out of the plate 10 in the centerof the circle with tapers or ramps on either side. The hole 24A is notelongated, but is generally circular and the non-locking fastener 40will be allowed to translate in the hole 24A because the diameter of thehead portion 42 and/or shaft (e.g., bone thread) will be smaller thanthe size of the hole 24A in the plate 10. With respect to hole 22A, thetextured portion 26A of the hole 22A may be in the form of a taperedthread. This tapered thread may generally correspond to a similartapered thread on the locking fastener 30. This hole 22A also does notinclude a tapered portion, and the textured portion 26A begins at theintersection with the top surface 16 of the plate 10. This alternativeopening 20A also provides for the use of both locking and non-lockingfasteners 30, 40 that are able to dynamically compress bone and/or lockthe plate 10 to the bone.

Turning now to FIGS. 5A-5C, the combination opening 20B is similar toother combination openings except that the locking hole 22B includes adifferent type of textured portion 26B. The textured portion 26Bincludes a series of alternating recesses and protrusions around acentral portion of the hole 22B. The recesses may be in form of a waveof alternating cutouts extending around the inner perimeter of the hole22B. The textured portion 26B may lock the fastener 30 with a frictionfit or may be modified during insertion of the fastener 30 to form alock in situ. In this embodiment, the locking hole may allow forpolyaxial locking. The plate 10 and the locking fastener 30 may be madeof dissimilar materials having dissimilar hardness values. For example,the fastener 30 may have a higher hardness (e.g., on the Rockwell scale)relative to the plate 10, which may be formed of a material having alower relative hardness value. Due to the increased hardness, the headportion 32 of the locking fastener 30 may create a thread in the plate10 as the fastener 30 is inserted (e.g., threaded) into the hole 22B,thereby locking the fastener 30 to the plate 10.

With reference to FIGS. 6A-6C, the opening 20C includes locking hole 22Cand dynamic compression hole 24C with a more open configuration. Thelocking portion 22C has a textured portion 26C in the form of a taperedthread. This tapered thread may generally correspond to a similartapered thread on the locking fastener 30. The opposite portion 24C ofthe opening 20C is oblong with a ramp 25C milled into the top surface 16of the plate 10 to allow for dynamic compression. As best seen in FIG.6C, the ramp may be partially spherical in shape and extend from the topsurface 16 of the plate 10 and connect to the textured portion 26C. Whenviewed from above in FIG. 6B, the ramp 25C creates a square-like,key-hole, and/or non-hole geometry that sweeps into the tapered threadedlocking hole 22C. This alternative opening 20C also provides for the useof both locking and non-locking fasteners 30, 40 that are able todynamically compress bone and/or lock the plate 10 to the bone.

Turning now to FIGS. 7A-7C, the opening 20D includes locking hole 22Dand dynamic compression hole 24D. These holes 22D, 24D are connected andclose together but are not overlapping. The holes 22D, 24D are separatedby a small portion or sliver of plate material proximate to the lowerportion of the holes 22D, 24D (e.g., at bottom surface 18 of the plate10 and partially extending between the holes 22D, 24D). The lockingportion 22D has a textured portion 26D in the form of a tapered thread.The textured portion 26D extends around almost the entire circumferenceof the hole 22D except where connected to hole 24D. The dynamiccompression hole 24D is elongated and has ramped portions 25D onopposite sides of the hole 24D to receive fastener 40. Thisconfiguration allows for a very close population of holes 22D, 24D onthe plate 10 while giving structural stability at the holes 22D, 24D.

With reference to FIGS. 8A-8C, locking hole 22E and dynamic compressionhole 24E are adjacent, but separate from one another. The holes 22E, 24Eare completely separated from one another by a wall 56 of platematerial. The locking portion 22E has a textured portion 26E in the formof a tapered thread extends around the entire perimeter of the hole 22E.The dynamic compression hole 24E is elongated and has ramped portions25E on opposite sides of the hole 24E. This configuration also allowsfor a very close population of holes 22E, 24E on the plate 10 whilegiving options for both locking and/or dynamic compression.

Turning now to FIGS. 9A-9D, an alternative version of opening 20F isprovided. In this embodiment, the hole construct 20F is comprised of atleast three overlapping conical threaded holes in the plate 10. Theopening 20F includes a first, locking hole 22F, a second hole 24F, and athird hole 23F arranged along a longitudinal axis of the plate 10. Thethird hole 23F is the mirror image of hole 24F across the first lockinghole 22F. The conically threaded holes 22F, 23F, 24F may or may not haveparallel axes. Each hole 22F, 23F, 24F may include a textured portion26F, for example, in the form of one or more threaded portions. Thus,the locking fastener 30 may lock to any of the holes 22F, 23F, 24F.Although each of the holes 22F, 23F, 24F are shown in with the texturedportion 26F, it will be appreciated that one or more of the holes 22F,23F, 24F may have a substantially smooth inner portion instead of thetextured portion 26F. The upper part of the hole construct at the firstand second ends of the hole 20F each have a ramped feature 25F (e.g.,adjacent to holes 23F and 24F) to allow for dynamic compression of theplate 10. In addition, the ramped feature 25F may span the three or moreconical holes 22F, 23F, 24F (e.g., around the entire perimeter of theopening 20F).

The non-locking compression fasteners 40 may have a major bone threaddiameter such that the fastener 40 can translate between overlappingholes 22F, 24F, 23F without interference. As best seen in FIG. 9D, thelocking fastener 30 may include a textured area 36, for example, in theform of a thread, configured to engage with the textured portion 26F ofany of the holes 22F, 23F, 24F. The hole geometry of opening 20F can beapplied to bone plates 10 to utilize either fixed angle and/or variableangle locking screws 30 and/or polyaxial non-locking screws 40 that canachieve dynamic compression. This allows surgeons more flexibility forscrew placement, based on preference, anatomy, and fracture location.

Turning now to FIGS. 10A-10B, another embodiment of opening 20G isprovided. This opening 20G may be comprised of one elongate hole or slotextending from the top surface 16 to the bottom surface 18 of the plate10. A locking portion 22G of the opening 20G may include a texturedportion 26G having straight machine threads. The threads may extend morethan 180 degrees to retain the locking fastener 30. A non-lockingportion 24G of the opening 20G may be positioned opposite the lockingportion 22G to complete the opening 20G. The upper part of the opening20G may have one or more ramped features 25G to allow for dynamiccompression of the plate 10. The ramp 25G may span along the entireupper perimeter of the elongated slot 20G or a portion thereof. Thecompression screws 40 may have a major bone thread diameter such thatthe screws 40 are able to translate along the opening 20G withoutinterference.

With reference to FIGS. 11A-11E, alternative embodiments of the lockingfastener 30 may be used with any plate 10. The head portion 32 of thefastener 30 may include a textured area 36 in the form of a thread, forexample, to lock the fastener 30 to the plate 10. The fastener 30 and/orplate 10 may also include one or more mechanisms to prevent back out ofthe fastener 30 from the plate 10. In FIG. 11A, the head portion 32includes at threaded portion 36A (e.g., having straight threads) thatinterface with the plate 10 and the top of the head extends larger thanthe threads. The head portion 32 bottoms out when the fastener 30 isfully inserted and creates preload in the fastener 30, thus locking thefastener 30 rotationally. In FIG. 11B, the head portion 32 includesthreaded portion 36B. The head portion 32 has a constant major diameterwhile the minor diameter is tapered. The thread depth may go to zero atthe top of the head portion 32 of the screw 30. The first few turnssmoothly insert, but as the tapered portion of the male thread engageswith the plate 10, interference occurs, jamming and/or locking the screw30 and preventing backout. In FIG. 11C, a screw thread 36C on the headportion 32, similar to the design in FIG. 11B, except the minor diameterof the screw 30 stays constant while the major diameter of the headportion 32 gets larger toward the top of the screw 30. A similar jammingand locking mechanism results through tightening of the screw 30 in theplate 10. In FIG. 11D, the threaded portion 36D has areas of varyingpitch. In particular, a straight screw thread on the head portion 32 ofthe screw 30 has a similar pitch to that of the plate 10 at the bottomof the head portion 32 of the screw 30. The pitch then increases ordecreases towards the top of the head portion 32, which thereby resultsin jamming of the threads and preventing unwanted backout of the screw30. In an alternative variation of the concept of FIG. 11D, shown inFIG. 11E, the opening in the plate 10 is provided with areas of varyingpitch while the pitch of the threaded portion 36D remains constant. Forexample, the head portion 32 may include a straight thread with aconstant pitch. The upper surface of the plate 10 may include a threadpitch is similar to that of the screw 10, but towards the bottom surfaceof the plate 10, the thread pitch would either increase or decrease tolock the screw 30 to the plate 10.

Turning now to FIGS. 12A and 12B, the plate 10 includes an additionalanti-backout feature. In this embodiment, the plate 10 includescylindrical holes or openings 20H configured to accept either thecompression fastener 40 or the locking fastener 30. Each opening 20H mayinclude a ramped portion 25H extending around a portion or the entireperimeter of the opening 20H to allow for dynamic compression with acompression fastener 40. Each opening 20H may include a cylindricalfeature to provide angular stability with a locking fastener 30. Theopening 20H may also include an angular taper 28 to cause compressivetightening between the locking fastener 30 and the cylindrical opening20H. Each opening 20H has an accompanying blocking screw 46 that can beactuated to block the fastener 30, 40 from backing out. The blockingscrew 46 may extend from a first end at the top surface 16 to a secondend at the bottom surface 18 of the plate 10. The first end of theblocking screw 46 may include a recess sized to receive an instrument torotate the blocking screw 46 from an unblocked position to a blockedposition. The blocked position may include a portion of the blockingscrew 46 covering a portion of the head portion 42 of the fastener 40,thereby further preventing backout of the fastener 40 from the plate 10.

According to yet another embodiment, the plate 10 may include one ormore openings 20 configured to receive the locking fastener 30 havingself-forming threads that work by displacement of the plate material tolock the fastener 30 to the plate 10. Turning now to FIGS. 13-18, thelocking fastener 30 and alternative embodiments of the openings 20 inthe plate 10 are shown. In these embodiments, the locking mechanism ofthe fastener 30 (e.g., bone screw) to the internal fixation plate 10 mayallow for variable angle screw insertion. The fastener 30 may beinserted within an angular cone where the force required to dislodge thehead portion 32 of the fastener 30 is substantially equivalent to theforce required when the fastener 30 is inserted perpendicular to theplate 10. The holes or openings 20 in the plate 10 may be shaped suchthat the fastener 30 may be inserted at different angles. The geometryof the opening 20 is conducive to catching the threads on the headportion 32 of the fastener 30 and to reduce the axial force necessary toinitiate the thread formation.

The locking mechanism includes a fastener 30 having a head portion 32with self-forming threads that displace the plate material. The plate 10may be made of a material softer than the fastener 30 to facilitatedisplacement. For example, the plate 10 may be comprised of titanium,alloys, polymers, or other materials having a lower material hardness(e.g., Rockwell hardness). The fastener 30 may be made of a harderrelative material, for example, comprised of cobalt chrome, tungsten,alloys, or other materials having a higher material hardness.Preferably, the fastener 30 is comprised of a material having a strong,stiff, and high surface hardness which facilitates the thread formingprocess. The forming mechanism works by displacement of material ratherthan removal of the material of the plate 10, thereby minimizingfragments or chips which are created from tapping.

In FIGS. 13A-13B, the locking fastener 30 includes a head portion 32 anda shaft portion 34 configured to engage bone. Although not shown, theshaft portion 34 may be threaded such that the fastener 30 may bethreaded into the bone. The head portion 32 may be tapered (e.g., at anangle of about 20°) such that the fit within the opening 20 in the plate10 becomes tighter as the fastener 30 is advanced in to the bone. Thehead portion 32 of the locking fastener 30 includes a textured area 36around its outer surface sized and configured to engage an opening 20 inthe plate 10. The textured area 36 may include threads, ridges, bumps,dimples, serrations, or other types of textured areas. As shown, thetextured area 36 preferably includes a threaded portion extendingsubstantially from the top of the head portion 32 to the bottom of thehead portion 32 proximate to the shaft portion 34. The threads 36 mayrun generally perpendicular to the conical surface of the head portion32. The threaded portion 36 is in the form of self-forming threadsconfigured to displace the plate material and create threads in theopening 20 of the plate 10. The threaded portion has an exaggeratedsharp thread peak to facilitate cutting or forming of the platematerial.

Turning now to FIGS. 14-17, alternative versions of the openings 20 areshown before being tapped with the fastener 30. Once the fastener 30 isinserted, these openings 20 are modified based on the self-formingthreads. The geometry of the openings 20 are conducive to catching thethreads 36 and designed to reduce the axial force necessary to initiatethe thread formation. An upper portion of the hole 20 may be tapered 28,for example, with a conical straight tapered surface cut through the topsurface 16 of the plate 10 for clearance of the head portion 32 of thefastener 30 during off angle insertion. A lower portion of hole 20 mayfurther be tapered 29, for example, with a conical straight taperedsurface cut through the bottom surface 18 of the plate 10 for clearanceof the shaft portion 34 during off angle insertion. The upper taperedportion 28 may be larger, for example, with a larger degree of taperthan the lower tapered portion 29. For example, the upper taperedportion 28 may have a taper in a range from about 60-90°, 70-80°, or72-78°, preferably about 70°, 75°, or 80° whereas the lower taperedportion 29 may have a taper in a range from about 50-70°, 55-65°, or57-63°, preferably about 55°, 60°, or 65°. The upper and/or loweredtapered portions 28, 29 may be substantially conical (e.g., FIG. 14B,15B, 16B) or may be segmented with more than one section, such as twoseparate conical sections having different diameters or degrees of taper(e.g., FIGS. 17A and 17B).

At the intersection between the upper tapered portion 28 and the lowertapered portion 29 a narrowed central portion may have a texturedportion 26. As described herein, the textured portion 26 may includethreads, ridges, bumps, dimples, serrations, or other types of texturedareas. In the embodiment shown in FIGS. 14A-14B, the textured portion 26includes a windswept cut design comprised of a plurality of shallow cutswhere each cut overlaps the next. For example, the windswept design mayinclude a plurality of threadlike helical cut sweeps. Each cut has asmooth transition into the inner diameter of the hole 20 (e.g., into theupper and lower tapered portions 28, 29). The windswept cuts provide apositive surface for the self-forming threads to cut into, therebyhelping to prevent peeling of the newly formed threads into the plate10.

In FIGS. 15A-15B, the textured portion 26 includes a knurled cut design.A rounded transition between the upper tapered portion 28 and the lowertapered portion 29 (e.g., the two conical cuts) provides a workablesurface for the knurling process as well as a surface for the headportion 32 to be able to roll over during off-axis locking. The knurleddesign may include a plurality of shallow knurled grooves set in adiamond pattern (e.g., about 45°) where each cut overlaps the next. Theknurled grooves allow for the self-forming threads to cut more deeplyinto the material and reduce the necessary axial force to begin thethread forming process. FIGS. 16A-16B depict a polygon form cut design.In this design, there is no textured portion at the transition betweenthe upper tapered portion 28 and the lower tapered portion 29. Instead,the narrowed central region has an overall polygonal form such that thehole 20 is neither cylindrical nor conical. The polygonal shape includesa number of sides with distinct linear section of material and roundedcorners around which the form cut is allowed to sweep. For example, thepolygonal shape may be substantially hexagonal (6-sided), heptagonal(7-sided), octagonal (8-sided), etc. The hole 20 may also be representedwithout lobe cuts, as a single concentric ring with the same geometry.

In FIG. 17A, the upper tapered portion 28 includes a conical straighttapered surface cut for clearance of the head portion 32 of the fastener30 during off angle insertion. The upper tapered portion 28 is segmentedto have an upper area with a larger area relative to a lower areaproximate the transition to the lower tapered portion 29 having anarrower diameter. The central area between the upper and lower taperedportions 28, 29, where the thread forming process occurs, includes twopeaks or concentric rings of material (e.g., a superficial ring 60 and adeep ring 62) with a groove 27 being locating in between for materialremoval and thread forming relief. The groove 27 between the rings 60,62 may be angled, for example, in the range of about 40-80°, about50-70°, or about 60°. The superficial ring 60 is of a slightly smallerinner diameter than the deep ring 62, as the superficial ring 60 isresponsible for supporting a majority of the cantilever loads. The deepring 62 provides additional fixation and support during off-angleinsertion as well as additional support during nominal trajectoryinsertion. The lower tapered portion 29 includes a straight taperedsurface that provides clearance for the shaft 34 of the fastener 30 wheninserted off angle.

The embodiment of the opening 20 in FIG. 17B is similar to FIG. 17A, butfurther includes textured portion 26 in the form of a plurality ofhelical swept cuts at the transition between the upper tapered portion28 and the lower tapered portion 29. The shallow helical cuts orwindswept cuts may include a series of cuts at a steep pitch. Thewindswept cuts may be angled, for example, at about 50-70°, or about60°. The same number of cuts may be made in both a clockwise andcounter-clockwise fashion. The cuts may create plateaus of materialprotruding into the opening 20. The resultant geometry provides positivesurfaces for the fastener 30 to cut into, which can dramatically reducethe axial force necessary to lock the fastener 30 to the plate 10. Thusmechanism does not need to rely on bone purchase in order to engage thethreads in the head portion 32 of the fastener 30. The material removedduring insertion of the fastener 30 allows the self-forming threads tocut deeper by removing material which much be formed and reducingfriction between the fastener 30 and the plate 10 during the formingprocess.

FIGS. 18A-18D depict a screw-plate assembly. The assembly, in FIG. 18C,shows the locking fastener 30 placed at an angle, other thanperpendicular, to the upper surface 16 of the plate 10. In FIG. 18D, anon-locking fastener 40 is placed generally perpendicular to the plate10. It will be appreciated that the locking fastener 30 and non-lockingfastener 40 may be oriented at any appropriate angle relative to theplate 10. The section view in FIG. 18C shows the thread engagement withthe plate 10 in which material of the plate 10 is displaced around thethreads of the fastener 30. By using the self-forming threads, thefastener 30 is able to be inserted into the plate 10 at variable anglesand engages with the plate 10 with one-step locking requiring noadditional steps to lock the fastener 30 to the plate 10. The sectionview in FIG. 18D show the compressive, non-locking screw 40 received inthe opening 20, without threadedly locking thereto. The non-lockingscrew 40 may provide for dynamic compression of the bone. Accordingly,the fasteners and openings described herein provide a wide variety ofoptions for the surgeon, thereby providing appropriate locking and/orunlocking capability for dynamic compression depending on the desiredtreatment of the fracture and the bone.

Dia-Meta Volar Distal Radius Plate System

FIG. 19 depicts embodiments of a dia-meta volar distal radiusstabilization system 200 including a bone plate 210 configured to sitagainst the volar side of the radial bone and one or more bone fastenersare configured to be received in the bone plate 210 and secured to theradius and radial shaft of a bone. Although generally described withreference to the radius and radial shaft, it will be appreciated thatthe stabilization system 200 described herein may be used or adapted tobe used for the fixation of other long bones as well, such as thehumerus, femur, tibia, etc.

The bone plate 210 extends from a first end 212 configured to bepositioned on a shaft portion of radial bone to a second end 214configured to be positioned proximate to the distal end of the radius.The plate 210 includes a top surface 216 and an opposite, bottom surface218 configured to contact adjacent bone. The top and bottom surfaces216, 218 are connected by opposite side surfaces extending from thefirst to second ends 212, 214 of the plate 210. The bottom surface 218of the plate 210 includes an anatomic contour configured to follow thebest approximation of average distal radial anatomy, flaring up slightlyalong the radial column and more significantly along the intermediatecolumn of the plate 210. The plate 210 is designed to sit low and have agenerally low profile proximal portion. The thickness of the plate 210may generally be about 2 mm along the shaft and distal intermediatecolumn, tapering to a thickness of 2.5 mm along the distal radial columnwhich allows for the severe angle of the radial styloid fastener. Thethickness of the plate 210 may generally increase towards the first end212 when compared to the second end 214. In addition, the width of theplate 210 proximate the first end 212 and along the elongate portion 240may be thicker than the width of the plate at the second end 214. Thedesign of plate 210 allows for an easy transition from the second end214 of the plate 210 to the elongate portion 240 to the first end 212 ofthe plate 210 to address fractures proximal to the second end of theplate 214 while also providing adequate support in the radial shat ofthe bone.

The second end 214 of the bone plate 210 toward the elongate portion 240of the bone plate 210 is very similar to the bone plate 110, thus thefeatures and disclosures set forth above relating to the bone plate 110are equally applicable to bone plate 210 and are incorporated in theirentirety herein.

Looking at the elongate portion or dia-meta portion 240 of the plate210, the plate 210 includes one or more through openings 220 configuredto receive one or more bone fasteners. The openings 220 extend throughthe body of the plate 210 from the top surface 216 to the bottom surface218. The openings 220 may include cylindrical openings, conicalopenings, elongated openings, threaded openings, textured openings,non-threaded and/or non-textured openings, and the like. The openings220 may allow for locking of the fastener to the plate 210 or may allowfor movement and dynamic compression of the bone. The plate 210 maycomprise any suitable number of openings 220 in any suitableconfiguration. These openings 220 allow surgeons more flexibility forfastener placement, based on preference, anatomy, and fracture location.Surgeons may have differing opinions as to the number, location, andtypes of fasteners. Further, complexity of fracture location and shapemakes having as many locations for fasteners as possible necessary. Thisdesign offers surgeons a versatile method to achieve higher accuracy inplacement of the fasteners.

The openings 220 may be configured to receive one or more bonefasteners. The fasteners may include locking fasteners, non-lockingfasteners, or any other fasteners known in the art. The fasteners maycomprise bone screws or the like. The fasteners may also include otherfasteners or anchors configured to be secured or engaged with bone, suchas nails, spikes, staples, pegs, barbs, hooks, or the like. Thefasteners may include fixed and/or variable angle bone screws. Thefastener may include a head portion and a shaft portion configured toengage bone. For a locking fastener, the shaft portion may be threadedsuch that the fastener may be threaded into the bone. The head portionmay include a textured area, such as threads, around its outer surfacesized and configured to engage with the opening 220, for example, andcorresponding threads in the opening 220 in order to lock the fastenerto the plate 210. In the alternative, for a non-locking fastener, thehead portion may be substantially smooth to allow for dynamiccompression of the bone.

The plate 210 may further comprise a plurality of openings 224configured to receive one or more k-wires (not shown). The k-wire holes224 may comprise small diameter holes (e.g., having a diametersignificantly smaller than the fastener openings 220). The k-wire holes224 may allow preliminary placement of the plate 210 against the boneand/or to aid in reduction of the fracture. The distal k-wire holes 224on the head portion 242 may ensure a trajectory to follow the RC jointand provide direction during insertion of the distal locking screws. Theproximal k-wire holes in the elongated portion 240 of the plate 210 arearrange between fastener openings 220 and may be angled relative to thesurface of the plate 210 to avoid intrusion into areas whereinstrumentation must pass during screw insertion.

Dorsal Plate System

FIGS. 20-24 depict embodiments of a dorsal stabilization system 300including bone plates 310, 410 which are configured to sit against thedorsal portion of bone. One or more bone fasteners 320C are configuredto be received in the bone plates 310, 410 to secure the plates 310, 410to the dorsal portion of a bone. Although generally described withreference to the dorsal portion of bone, it will be appreciated that thestabilization system 300 described herein may be used or adapted to beused for the fixation of other bones as well, such as other portions ofthe identified bones. It should be noted that the same referencenumerals are being used for plates 310, 410 because the plates aresimilar except for their respective first ends 312 which show differentopening 320 configurations. FIG. 20 shows an acute configuration andFIG. 22 shows an oblique configuration.

As shown in FIGS. 20-22, the plates 310, 410 each have a body thatextends from a first end 312 to a second end 314. The plates 310, 410each include a top surface 316 and an opposite, bottom surface 318configured to contact adjacent bone. The top and bottom surfaces 316,318 are connected by opposite side surfaces extending from the first tosecond ends 312, 314 of the plate 310. Although the plate 310, 410 areshown having a generally longitudinal body, it will be appreciated thatany suitable shape and contouring of the plates may be provideddepending on the location and type of fracture to be plated.

The bone plates 310, 410 include one or more openings 320. The openings320 extend through the plate 310, 410 from the upper surface 316 to thebottom surface 318 and are configured to accept locking fasteners andnon-locking fasteners 320C. When using the plates 310, 410 with bone,surgeons may use only locking, only non-locking or a combination of bothlocking and non-locking fasteners to connect the bone and the plates310, 410. The openings 320 may be in the form of any of the openingsdiscussed above with respect to the volar distal radial plate system,the dia-meta plate system, and the alternative hole configurations.

The plates 310, 410 also include one or more slots 320C present alongthe elongated portion 340 of the plates 310, 410 and configured toaccommodate a sliding fastener 322C, shown in FIGS. 23 and 24. As bestseen in FIGS. 20-24, the slot 320C may offer a sliding slot forproximal-distal adjustment of the plates 310, 410 during provisionalplacement. The slot 320C may allow for proximal adjustment, distaladjustment, and/or medial-lateral adjustment of the plates 310, 410.This allows surgeons to optimally center the plate position along thebone prior to locking screw insertion. The slot 320C may be elongatedalong a longitudinal axis of the elongated portion 340 as well aselongated, perpendicular to the longitudinal axis, from lateral side tolateral side. The elongated slot 320C may have varying lengths and/orwidths. Preferably, the length is greater than the width of the slot320C. The plates 310, 410 may include etch lines adjacent to slot 320Cfor more accurate adjustment of the plate 310 when being positioned onbone.

As best seen in FIGS. 20 and 22, plates 310, 410 also may include aplurality of side relief cuts or scalloped edging 322 along the lengthof the plates 310, 410 which allows the plates 310, 410 to be bent, forexample, in three dimensions. The side relief cuts or scalloped edges322 may be in the form of one or more curves having a widened portionalong the sides of the plates 310, 410 and a narrowed portion towardsthe center of the plates 310, 410. The side relief cuts or scallopededges 322 may be positioned between consecutive openings 320. Theplurality of relief cuts or scalloped edges 322 may form a scalloped orwavy profile along the side edges of the plates 310, 410. As a result,the plates 310, 410 are able to be shaped to a multi-contour surfacewithout warping the openings 320.

The plates 310, 410 may further comprise a plurality of openings 324configured to receive one or more k-wires (not shown). The k-wire holes324 may comprise small diameter holes (e.g., having a diametersignificantly smaller than the fastener openings 320). The k-wire holes324 may allow preliminary placement of the plates 310, 410 against thebone and/or to aid in reduction of the fracture.

Lateral Plate

FIGS. 25-27 depict embodiments of a lateral stabilization system 500including bone plate 510 which is configured to sit against the lateralportion of bone to address fractures on the side of the radius. One ormore bone fasteners 520C are configured to be received in the bone plate510 to secure the plate 510 to the lateral portion of a radius of abone. Although generally described with reference to the lateral portionof the radius of the bone, it will be appreciated that the stabilizationsystem 500 described herein may be used or adapted to be used for thefixation of other bones, such as long bones, as well as other portionsof the identified bones.

The plate 510 has a body that extends from a first end 512 to a secondend 514. The plate 510 includes a top surface 516 and an opposite,bottom surface 518 configured to contact adjacent bone. The top andbottom surfaces 516, 518 are connected by opposite side surfacesextending from the first to second ends 512, 514 of the plate 510.Although the plate 510 is shown having a generally longitudinal body,that contours or radius upwardly to accommodate distal radius bonyanatomy, it will be appreciated that any suitable shape and contouringof the plates may be provided depending on the location and type offracture to be plated.

The bone plate 510 includes one or more openings 520. The openings 520extend through the plate 510 from the upper surface 516 to the bottomsurface 518 and are configured to accept locking fasteners andnon-locking fasteners 520C. When using the plate 510 with bone, surgeonsmay use only locking, only non-locking or a combination of both lockingand non-locking fasteners to connect the bone and the plate 510. Theopenings 520 may be in the form of any of the openings discussed abovewith respect to the volar distal radial plate system, the dia-meta platesystem, the dorsal plates and the alternative hole configurations.

The plate 510 also includes one or more slots 520C present along theelongated portion 540 of the plate 510 and configured to accommodate asliding fastener 522C, shown in FIG. 27. As best seen in FIGS. 25-26,the slot 520C may offer a sliding slot for proximal-distal adjustment ofthe plate 510 during provisional placement. The slot 520C may allow forproximal adjustment, distal adjustment, and/or medial-lateral adjustmentof the plate 510. This allows surgeons to optimally center the plateposition along the bone prior to locking screw insertion. The slot 520Cmay be elongated along a longitudinal axis of the elongated portion 540as well as elongated, perpendicular to the longitudinal axis, fromlateral side to lateral side. The elongated slot 520C may have varyinglengths and/or widths. Preferably, the length is greater than the widthof the slot 520C. The plate 510 may include etch lines adjacent to slot520C for more accurate adjustment of the plate 510 when being positionedon bone.

As best seen in FIGS. 25 and 27, plate 510 also may include a pluralityof side relief cuts or scalloped edging 522 along a portion of thelength of the plate 510 which allows that portion of the plate 510 to bebent, for example, in three dimensions. The side relief cuts orscalloped edges 522 may be in the form of one or more curves having awidened portion along the sides of the plate 510 and a narrowed portiontowards the center of the plate 510. The side relief cuts or scallopededges 522 may be positioned between consecutive openings 520. Theplurality of relief cuts or scalloped edges 522 may form a scalloped orwavy profile along the side edges of the plate 510. As a result, aportion of the plate 510 is able to be shaped to a multi-contour surfacewithout warping the openings 520.

The plate 510 may further comprise a plurality of openings 524configured to receive one or more k-wires (not shown). The k-wire holes524 may comprise small diameter holes (e.g., having a diametersignificantly smaller than the fastener openings 520). The k-wire holes524 may allow preliminary placement of the plate 519 against the boneand/or to aid in reduction of the fracture.

Bridge Plate

FIG. 28 depicts an embodiment of a stabilization system 600 includingbone plate 610 which acts as an internal fixator for high energycomminuted distal radius fractures. The plate 610 is placed dorsally andextends from the third or second metacarpal to approximately a third tohalf way down the radius. One or more bone fasteners are configured tobe received in the bone plate 610 to secure the plate 610 to the desiredportions of bone. Although generally described with reference to theradius and metacarpals, it will be appreciated that the stabilizationsystem 600 described herein may be used or adapted to be used for thefixation of other bones, such as long bones, as well as other portionsof the identified bones.

The plate 610 has a body that extends from a first end 612 to a secondend 614. The plate 610 includes a top surface 616 and an opposite,bottom surface 618 configured to contact adjacent bone. The top andbottom surfaces 616, 618 are connected by opposite side surfacesextending from the first to second ends 612, 614 of the plate 610.Although the plate 610 is shown having a generally longitudinal bodythat is generally planar, it will be appreciated that any suitable shapeand contouring of the plates may be provided depending on the locationand type of fracture to be plated.

The bone plate 610 includes one or more openings 620. The openings 620,which are located proximate the first end 612 and the second end 614,extend through the plate 610 from the upper surface 616 to the bottomsurface 618 and are configured to accept locking fasteners andnon-locking fasteners. When using the plate 610 with bone, surgeons mayuse only locking, only non-locking or a combination of both locking andnon-locking fasteners to connect the bone and the plate 610. Theopenings 620 may be in the form of any of the openings discussed abovewith respect to the volar distal radial plate system, the dia-meta platesystem, the dorsal plates, the lateral plates and the alternative holeconfigurations.

Lunate Facet Hook Plate

FIGS. 29-31 depicts an embodiment of a stabilization system 700including hook plate 710 which is designed for fracture patterns thatinvolve the volar ulnar corner of the distal radius. The plate 710 maybe used as a stand-alone stabilization plate or may be used incombination with a volar distal radius plate 110, as shown in FIG. 31.

When the plate 710 is used alone, the hooks 712 of the plate areembedded or tapped into bone to prevent the shifting of the plate in alateral or medial direction. It is contemplated that there may one, two,or more hooks 712. The plate 710 also includes an opening 720 to receivea fixation screw 714, which may aid in further fixation of the plate 710the bone and the fracture site.

When the plate 710 is used with the volar distal radius plate, the plate710 is configured and dimensioned such that is can be slidably placedunder a pre-positioned volar distal radius plate 110. The opening 720will align with an opening 120 on the volar distal radius plate 110 suchthat a fastener will pass through the opening 120 on the volar distalradius plate 110 and the opening 720 on the plate 710. The opening 720can accept a locking screw or a non-locking screw.

FIGS. 32 and 33 show a lunate facet hook plate reduction instrument 810.The instrument is capable of being connected to any quick connect handleknown in the industry, such as the AO quick-connect handle. Thereduction instrument 810 utilizes a two-piece contact surface that iscapable of capturing a lunate facet hook plate and releasing the hookplate when it is positioned in the desired location and orientation.

FIGS. 34 and 35 depict a drill guide 910 that can be attached to secondend 114 of the volar distal radius plate 110. The drill guide 910 mayinclude a plurality of cannulated openings 912 which correspond to eachof the respective openings 120 in the plate 110. The drill guide 910openings 912 may be configured in order to drill the pilot holes at theappropriate trajectories for each opening 120, and subsequently receivethe respective fasteners at the correct trajectories. The drill guide910 may also include a plurality of k-wire openings 914 which match withthe k-wire openings in the plate 110. The drill guide 910 may be securedto the plate 110 with one or more fasteners or may be secured to theplate 110 through an integrated connection system such as a thumb screw,an interference fit, etc. The fastener may thread into the plate 110 orotherwise temporarily secure the drill guide 910 to the plate 110. Thedrill guide 910 may be pre-assembled to the plate 110 or may be attachedat any other suitable time before or during the surgery. The fastenermay be secured, for example, in the operating room, via thumb orhexalobular fastener, to attach the drill guide 910 to the plate 110.After the pilot holes are drilled, the drill guide 910 may then beremoved and the fasteners positioned through the respective openings120. The drill guide 910 may be relatively slim in thickness, forexample, not protruding more than 10 mm above the plate 110, to preventimpinging on soft tissue.

Although the invention has been described in detail and with referenceto specific embodiments, it will be apparent to one skilled in the artthat various changes and modifications can be made without departingfrom the spirit and scope of the invention. Thus, it is intended thatthe invention covers the modifications and variations of this inventionprovided they come within the scope of the appended claims and theirequivalents. It is expressly intended, for example, that all rangesbroadly recited in this document include within their scope all narrowerranges which fall within the broader ranges. It is also intended thatthe components of the various devices disclosed above may be combined ormodified in any suitable configuration.

What is claimed is:
 1. A stabilization system for stabilizing a bone,the system comprising: a bone plate, the bone plate comprising anelongated portion extending along a longitudinal axis, an enlarged headportion extending along a second axis from a first end to a second end,and a transition region connecting the elongated portion to the enlargedhead portion, the second end of the enlarged head portion is a free end,wherein the transition region is curved and connects to the first end ofthe enlarged head portion, wherein at least a portion of the elongatedportion extends along a curved trajectory, the bone plate comprising aplurality of through holes extending through the enlarged head portion,the transition region, and the elongated portion; a plurality offasteners configured to extend through one or more of the plurality ofthrough holes in the bone plate and configured to secure the bone plateto the bone, wherein the elongated portion includes a slot for receivinga sliding fastener for provisional alignment of the bone plate, andwherein the longitudinal axis and the second axis are generallyperpendicular.
 2. The stabilization system of claim 1, wherein theplurality of through holes includes a first plurality of fixed angleholes positioned in general alignment along the enlarged head portion,and the plurality of fasteners include a plurality of fixed anglefasteners configured to be received in the fixed angle holes, theplurality of fixed angle fasteners configured to be aimed at aradio-carpal joint and a distal radio-ulnar joint.
 3. The stabilizationsystem of claim 1, wherein the plurality of through holes includes apolyaxial hole positioned proximate to the end portion of the enlargedhead portion connected to the transition region, and the plurality offasteners include a polyaxial fastener configured to be received in thepolyaxial hole, the polyaxial fastener configured to be aimed at aradial styloid.
 4. The stabilization system of claim 1, wherein theelongated slot allows for proximal-distal and medial-lateral adjustmentof the plate.
 5. The stabilization system of claim 1, wherein thetransition region extends at an angle relative to the longitudinal axis.6. The stabilization system of claim 1, wherein the enlarged headportion extends at an angle relative to the transition region.
 7. Thestabilization system of claim 1, wherein the plurality of fastenersinclude fasteners having self-forming threads on a head portion of thefasteners, which are configured to lock to at least one of the pluralityof through holes on the plate.
 8. The stabilization system of claim 1,wherein the plate further comprises a second plurality of openingsconfigured as k-wire holes to receive one or more k-wires.
 9. Thestabilization system of claim 1, wherein the plate includes a pluralityrecesses located along the elongated portion between the through holes,and the plurality of recesses are configured to facilitate bending ofthe plate.
 10. A stabilization system configured to stabilize a radius,the system comprising: a bone plate, the bone plate comprising anelongated portion extending along a longitudinal axis, an enlarged headportion extending along a second axis from a first end to a second end,wherein the longitudinal axis and the second axis are generallyperpendicular, and a transition region connecting the elongated portionto the enlarged head portion, wherein the transition region is curvedand connected to the first end of the enlarged head portion, the secondend of the enlarged head portion is a free end, wherein at least aportion of the elongated portion includes scalloped edges, the boneplate comprising a plurality of fixed angle holes positioned in generalalignment along the elongated portion, a polyaxial hole positionedproximate to the end portion of the enlarged head portion connected tothe transition region, and an elongated slot on the elongated portion; aplurality of fixed angle fasteners configured to be received in thefixed angle holes; a polyaxial fastener configured to be received in thepolyaxial hole; a fastener configured to be received in the elongatedslot, wherein the elongated slot allows for proximal-distal andmedial-lateral adjustment of the plate.
 11. The stabilization system ofclaim 10, wherein the transition region extends at an angle relative tothe longitudinal axis.
 12. The stabilization system of claim 10, whereinthe enlarged head portion extends at an angle relative to the transitionregion.
 13. The stabilization system of claim 10, wherein the pluralityof fasteners include fasteners having self-forming threads on a headportion of the fasteners, which are configured to lock to at least oneof the plurality of through holes on the plate.
 14. The stabilizationsystem of claim 10, wherein the plate further comprises a secondplurality of openings configured as k-wire holes to receive one or morek-wires.
 15. The stabilization system of claim 10, wherein the plateincludes a plurality recesses located along the elongated portionbetween the through holes, and the plurality of recesses are configuredto facilitate bending of the plate.
 16. A stabilization system forstabilizing a bone, the system comprising: a first bone plate having anupper surface and a lower surface configured to contact the bone,wherein the first bone plate further has a first portion and a secondportion, the second portion generally perpendicular to the firstportion, the second portion extending in a different plane than thefirst portion, the first portion of the first bone plate comprising anopening for receiving a fixation member; the second portion of the firstbone plate including at least one edge that is capable of penetratingbone; and a second bone plate comprising an elongated portion, anenlarged head portion extending from a first end to a second end, and atransition region connecting the elongated portion to the first end ofenlarged head portion, the second end of the enlarged head portion is afree end, wherein the second bone plate is capable of being positionedover the first bone plate.
 17. The stabilization system of claim 16,wherein the second portion includes at least two hooks, each having atleast one edge capable of penetrating bone.
 18. The stabilization systemof claim 16, wherein the opening is elongated.
 19. The stabilizationsystem of claim 16, wherein the first bone plate is configured anddimensioned to be able to slide under the second bone plate.
 20. Thestabilization system of claim 16, wherein the first bone plate includesa first opening and the second bone plate includes a second opening, thefirst opening aligns with the second opening such that a fastener willpass through the first and second openings.